In this intensive masterclass, "Mastering Biopharmaceutical Analytical Characterization with ICH Q6B", the technical, regulatory, and commercial aspects of biopharmaceutical characterization will be covered. The course content is designed to provide valuable assistance to scientists working in or entering the biopharma space.
Through interactive sessions, attendees will gain an understanding of large molecule drug development and the analytical techniques required to determine recombinant protein structure for both innovative and biosimilar products.
With particular relevance for those seeking to understand the differences between small and large molecule development, improve their knowledge of required characterization methods, and strategically plan analytical approaches, this course will enable participants to master biopharmaceutical product characterization according to current industry practices and regulatory guidelines.
Detailed reviews of techniques for assessing primary structure, post-translational modifications, higher order structure, and other critical quality attributes will demystify the array of analyses needed to adequately define novel and biosimilar biologic structure. Expert perspectives on meeting regulatory expectations will prepare attendees to plan and execute characterization studies that withstand scrutiny.
Fundamental Insights: Grasp the nuances of biopharmaceuticals, manufacturing processes, and regulatory essentials.
Analytical Challenges: Address critical questions about large complex molecules and understand protein and glycoprotein chemistry.
Detailed Product Characterization: Explore analytical methods for amino acid sequences, glycosylation, and more.
Physicochemical Mastery: Analyze molecular weight, size, isoform patterns, and delve into post-translational modifications.
Biosimilars Exploration: Gain insights into biosimilars, global regulations, and establishing biosimilarity.
Real-World Application: Conclude with case studies for a practical understanding.
Navigate the global regulatory landscape and comprehend the role of ICH guidelines in the development process.
Explore the drug development pipeline and understand when and why specific characterizations should be performed.
Develop a strategic perspective on the technical details required for successful large molecule drug development.
Dive into the intricacies of (glyco)protein structural characterization techniques.
Acquire practical knowledge through case studies, providing real-world insights into the challenges and solutions in large molecule characterization.
Explore effective strategies for product characterization, with a focus on both novel and biosimilar biopharmaceuticals.
Analyze case studies to understand successful approaches and potential pitfalls in product characterization.
Gain an in-depth understanding of regulatory requirements for biopharmaceutical product characterization.
Following a Ph.D. in Protein Biochemistry from Aberdeen University (1984) Dr Fiona Greer was a founding Director of M-Scan (Mass Spectrometry Consultants and Analysts), where she established and directed biologics characterization services. Here, she pioneered and applied new developments in mass spectrometry for structural analysis and sequencing of proteins and carbohydrates resulting in numerous publications and patents. She was instrumental in expansion of the group, establishing a US facility in 1988 where she was appointed VP. Following M-Scan’s acquisition in 2010, she became Global Director, Biopharma Services Development for SGS Life Sciences until 2019.
With nearly 40 years’ experience in glycoprotein analysis using mass spectrometry and other instrumental techniques, she has been involved with a diverse range of biotechnology products, both novel and biosimilar and now consults independently to companies throughout the world. She is regularly invited to give presentations and workshops at international meetings. She was named in the Medicine Maker “Power List – Top 100 industry influencers” in 2016, 2017 and 2018.
Richard obtained his PhD in glycoprotein structural characterization using mass spectrometry from Imperial College of Science, Technology and Medicine. He subsequently spent several years there as a postdoctoral research scientist working in the field of glycoprotein structural characterization with emphasis on glycan elucidation. He moved to GlaxoSmithKline for a short time where he was head of mass spectrometry for the toxicoproteomics and safety assessment group. Richard joined M-Scan Limited (now part of SGS Life Sciences) as a biochemist and became the Team Leader for Carbohydrate Analysis before being appointed Principal Scientist. Richard joined BioPharmaSpec in 2016 as Technical Director for Structural Analysis and is responsible for management of all aspects of carbohydrate and glycoprotein characterization at the primary structure level.
Chris has 25 years of experience working in the CRO field, primarily in the application of mass spectrometry and higher order structural characterization techniques to the analysis of a wide variety of pharmaceutical and biopharmaceutical products. Previously a member of the M-Scan group, he helped set-up BioPharmaSpec’s US laboratory in 2015. In his current role, Chris oversees BioPharmaSpec Inc’s laboratory operations, including the design and management of structural and physicochemical characterization studies for both novel and biosimilar biopharmaceuticals, including assessments of amino acid sequence, post-translational modifications (PTMs) such as glycosylation, higher order structure analysis and aggregation analysis, all of which are expected by regulatory authorities.